FDA Adverse Event Malfunction Summary report: N

COMPAT

MDR report key: 3019446 · Received March 21, 2013

Report

Report Number: 3019446
Event Type: Malfunction
Date Received: March 21, 2013
Date of Event: March 19, 2013
Report Date: March 21, 2013
Manufacturer: NESTLE HEALTHCARE NUTRITION, INC.
Product Code: LZH
Product Problem: Yes
Report Source: User Facility report
Reporter Location: MO, US

Narratives

Description of Event or Problem · 1

LOOSE SET SCREWS ON A SIGNIFICANT NUMBER OF NEWLY ACQUIRED NESTLE COMPAT FEEDING PUMP PERISTALTIC ROTOR HEAD ASSEMBLIES: THERE WERE 192 PUMPS ACQUIRED FOR DEPLOYMENT AT HOSPITALS WITHIN OUR HEALTHCARE SYSTEM: OF 140 UNITS AT FACILITY 1, ALL 140 THERE REQUIRED AT LEAST AN 1/8 INCH TURN TO TIGHTEN THE PUMP HEAD, 3 UNITS WERE COMPLETELY OFF AND 14 UNITS REQUIRED MORE THAN A 1/8 INCH TURN TO TIGHTEN. ALL 22 UNITS AT FACILITY 2 REQUIRED AT LEAST AN 1/8 INCH TURN ON THE SET SCREW. SIX UNITS AT FACILITY 3 REQUIRED AT LEAST AN 1/8 INCH TURN ON THE SET SCREW. SEVEN OUT OF 8 UNITS AT FACILITY 4 REQUIRED AT LEAST AN 1/8 INCH TURN ON THE SET SCREW. ONE UNIT WAS CRACKED. THE SCREW WAS OVER TIGHTENED. FACILITY 5 HAS DUO-FLO THOSE WERE CHECKED. AT FACILITY 6, 6 OUT OF 8 UNITS REQUIRED AT LEAST AN 1/8 INCH TURN ON THE SET SCREW AND AT FACILITY 7, 3 OUT OF 4 UNITS REQUIRED AT LEAST AN 1/8 INCH TURN ON THE SET SCREW.NESTLE REPS, WERE UNABLE TO PROVIDE VALUES FOR SET SCREW TORQUE. ALSO NOTED: THERE WAS NO LOCK-TIGHT TYPE MATERIAL FOUND IN USE ON THE SET SCREW. NONE HAS BEEN ADDED AT THIS TIME. WE ARE ALSO WAITING FOR SCHEDULED MAINTENANCE INFORMATION TO BE PROVIDED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SET SCREW SHOULD HAVE BEEN TIGHTENED CORRECTLY DURING MANUFACTURE OF THESE DEVICES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
117390	COMPAT	PUMP, INFUSION, ENTERAL	LZH	NESTLE HEALTHCARE NUTRITION, INC.	199235	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	*